Medical Policy

Policy Num:     02.002.038
Policy Name:   Coronary Intravascular Lithotripsy
Policy ID        [02.002.038][Ac/L/ M+ P+ ]0.00.00]

Last Review:    10/24/2024
Next Review:   10/20/2025
 

Related Policies:

Coronary  Intravascular Lithotripsy
 

Summary

 Intravascular lithotripsy (IVL) delivers unfocused, circumferential, pulsatile mechanical energy to safely disrupt calcium deposits within the target lesion. The IVL catheter is guided to the target lesion and an integrated balloon is inflated to four atmospheres. Once the catheter is in place, an electrical discharge vaporizes fluid inside the balloon. This action creates a rapidly expanding and collapsing bubble, generating sonic pressure waves. The sonic pressure waves travel through soft vascular tissue, cracking the intimal and medial calcium within the vessel wall. The balloon may be used to dilate the target lesion at a low pressure to maximize luminal gain. Angioplasty is included, when performed.

Coronary intravascular lithotripsy is used to prepare stenotic, calcified de novo coronary vessels for stent placement. Ultrasound waves are applied intravascularly to selectively breakup calcium deposits to aid with stent placement.

The physician treats coronary artery calcification, which is known to hinder other percutaneous coronary interventions, with percutaneous transluminal coronary lithotripsy. This procedure is performed in conjunction with other percutaneous transluminal or transcatheter coronary procedures (angioplasty, atherectomy, stent placement, revascularization of bypass graft or occlusion, or thrombolysis). Following femoral or radial access and using a proprietary intravascular lithotripsy (IVL) device, the physician advances the coronary catheter to the target lesion. An integrated balloon is inflated with fluid at a low pressure to contact the arterial wall. IVL is then activated, creating a small bubble within the catheter balloon that rapidly expands and collapses, resulting in shockwaves that travel through the innermost layer of the vessel wall, where it cracks the calcium by creating microfractures.

Summary of Evidence

CORONARY INTRAVASCULAR LITHOTRIPSY (IVL)

The evidence summary includes systematic reviews and randomized clinical trials not included in the systematic reviews.

 Systematic Reviews

Caminiti (2023) published a systematic review with meta-analysis to investigate the success rate of IVL for the treatment of stent underexpression (SU) because of coronary calcified plaque.[4] The meta-analysis included 13 studies with 354 patients, majority male (77%). The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm2 (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm2 (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in seven studies, the preIVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). The authors concluded that the “stent through” technique was safe to treat SU.

Mhanna (2022) published a systematic review evaluating the utility of adjunctive IVL.[5]The study included a total of eight single-arm observational studies, including 980 patients (1011 lesions), were included. 48.8% of the patients presented with acute coronary syndrome. Severe calcifications were present in 97% of lesions. Clinical success was achieved in 95.4% of patients (95%CI:92.9%-97.9%). Angiographic success was achieved in 97% of patients (95%CI:95%-99%). There was an overall increase in postprocedural lumen area as well as significant reduction of calcium angle and maximum calcium thickness. Most of the evidence of safety and effectiveness of Coronary IVL extends from the four prospective, nonrandomized, single arm, manufacturer sponsored, multisite DISRUPT CAD studies: Disrupt CAD I (NCT02650128); Disrupt CAD II (NCT03328949); Disrupt CAD III; and Disrupt CAD IV (NCT04151628). The following publications (systematic review with metaanalysis, meta-analysis, and a pooled analysis) discuss the results of these, as well as retrospective registry studies. [6-8]

 Satter (2022) published a meta-analysis for IVL outcomes in severely calcified coronary lesions.[6] The primary outcomes included clinical and angiographic success event ratios. The secondary outcomes included minimal lumen diameter (MLD), diameter stenosis (DS), lumen area, maximum calcium thickness, and calcium angle at minimal lumen area (MLA) and final minimal stent area (MSA). A total of seven studies (n = 760) were included. The DISRUPT CAD I – IV, a subgroup analysis of the DISRUPT CAD I study, and two registry (retrospective cohort analysis) studies. The primary outcomes: pooled clinical and angiographic success event ratio parentage of IVL was 94.4 % and 94.8 %, respectively. On a random effect model for standard inverse variance for secondary outcomes showed: minimal lumen diameter increase with IVL was 4.68 mm (p < 0.0001, 95 % CI: 1.69 to 5.32); diameter decrease in the stenotic area after IVL session was -5.23 mm (95 % CI: -22.6 to 12.8). At the MLA and final MSA sites, MLA gain was 1.42 mm2 (95 % CI: 1.06 to 1.63; p < 0.00001) and 1.34 mm2 (95 % CI: 0.71 to 1.43; p < 0.00001), respectively. IVL reduced calcium thickness at the MLA site (SMD -0.22; 95 % CI: -0.40 to 0.04; p = 0.02); calcium angle was not affected at the MLA site. The tertiary outcomes: most common complication was MACEs (n = 48/669), and least common complication was abrupt closure of the vessel (n = 1/669). The analysis was limited by inclusion of only single-arm observational studies. The definition of sever calcification was not uniform likely due to a lack of consistency of imaging type (ultrasound or optical coherence tomography). Only two studies reported diameter stenosis data. The post procedural outcomes did not include any form of adjunctive treatment (atherectomy or specialty cutting balloons). The authors suggest that more studies, including randomized, double-blind trials, are needed to study safety and efficacy in a head-to-head comparison with other debulking procedures.

Kereiakes (2021) published a pooled safety and effectiveness results from the four DISRUPT CAD I-IV studies.[7] Data was included from patients (n = 628) enrolled in 72 sites from 12 countries. The primary safety endpoint was a composite score of cardiac death, all myocardial infarction, or target vessel revascularization at 30 days. Procedural success was defined as stent delivery with a residual stenosis of >= 30% assessed by quantitative coronary angiography and without in-hospital major adverse CV events. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. The rate of in-hospital major adverse cardiovascular events was 6.5% (4.7% to 8.8%), driven by non-Qwave myocardial infarction (5.7%, 4.1% to 7.9%). The rate of 30-day major adverse cardiovascular events was 7.3% (5.4% to 9.7%), also driven by non-Q-wave myocardial infarction (5.9%, 4.2% to 8.1%). At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%, and rates of postprocedure and final serious angiographic complications were 2.1% and 0.3%, respectively, with no procedure associated perforations, abrupt closure, or episodes of no reflow, suggesting procedural success in treating both eccentric and concentric calcified lesions. Results of multivariate logistic regression show that treatment of bifurcation lesion (p = 0.006), prior myocardial infarction (p = 0.04), and lesion length ≥ 25 mm (p = 0.049) were independent predictors of 30-day major adverse cardiovascular events. Prior myocardial infarction (p = .016) and treatment of bifurcation lesion (P = .015) were predictors of lack of procedural success. Several of the authors of this analysis have professional affiliations with the device manufacture

. Sattar (2021) published a SR with meta-analysis examining the safety and efficacy of coronary IVL for left coronary calcified disease (LCAD).[8]They included four studies in their analysis (n = 282 patients) including results from the Disrupt CAD I and CAD II trials. In LCAD, ICL can yield lumen gain of up to 4.16 mm. The overall post-procedure lumen diameter was significantly higher than the pre-procedure diameter. The authors concluded that IVL offer a significant improvement in the vessel lumen to facilitate coronary stent delivery and deployments in severely calcified coronary arteries. They also indicated recommended that there is a need for randomized controlled trials and longer-term follow-up before recommending the routine use of Coronary Intravascular Lithotripsy. Sheikh (2021) published a systematic review assessing the efficacy and feasibility of IVL in treating severe coronary calcification.[9] The review included a total of 62 studies with 1389 patients (1414 lesions; 74.7% male patients with a mean age of 72.03 years) with significant coronary calcification or under-expanded stents underwent IVL. Significant improvement was demonstrated in acute and sustained vessel patency with a procedural success rate of 78.2 – 100% in hospital. The authors conclude that recent studies have highlighted that the use of IVL with adjuvant intracoronary imaging has revolutionized the way of treating heavily calcified, non-dilatable coronary lesions and is likely to succeed the conventional ways of treating these complex lesions. And that further studies are needed to gauge the long-term efficacy and safety of IVL against techniques currently available for calcium modification including conventional balloons, cutting or scoring balloons, rotational atherectomy and laser atherectomy.

 Randomized Controlled Trials

Two studies published in 2023 reported the results of the ROTA shock trial.[10, 11] The ROTA shock study is a randomized, prospective, non-blinded, double-arm, multicenter non-inferiority trial. Patients (n=70) were randomly (1:1) assigned to undergo either IVL or rotational atherectomy (RA) before percutaneous coronary intervention of severely calcified coronary lesions. The mean patient age was 73.3 ± 7.2 years, and the majority were male (75.4%). The primary endpoint minimal stent area (MSA) was lower but non-inferior after IVL (mean: 6.10 mm2 , 95% confidence interval [95% CI]: 5.32-6.87 mm2 ) versus RA (6.60 mm2 , 95% CI: 5.66-7.54 mm2 ; difference in MSA: -0.50 mm2 , 95% CI: -1.52-0.52 mm2 ; non-inferiority margin: -1.60 mm2 ). Stent expansion was similar (RA: 0.83 ± 0.10 vs. IVL: 0.82 ± 0.11; p = 0.79). There were no significant differences regarding contrast media consumption (RA: 183.1 ± 68.8 vs. IVL: 163.3 ± 55.0 mL; p = 0.47), radiation dose (RA: 7269 ± 11288 vs. IVL: 5010 ± 4140 cGy cm2; p = 0.68), and procedure time (RA: 79.5 ± 34.5 vs. IVL: 66.0 ± 19.4 min; p = 0.18). Two patients randomized to IVL were required to crossover to the RA group. In addition to small sample size and gender bias, limitations included a lower threshold for non-inferiority than originally predicted and the baseline vessel dimensions and reference vessel area in final OCT scans were larger in the RA than in the IVL group, leading to a bias for the comparison of MSA between these two groups.[10] An additional evaluation of the ROTA shock trial compared plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). They concluded that RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

A 2023 prospective single center randomized study to investigate if pre-treatment with IVL in severely calcified lesions increases stent expansion, assessed by optical coherence tomography (OCT), when compared to predilatation with conventional and/or specialty balloon strategy.[12] A total of 40 patients were included. The minimal stent expansion in the IVL-group (n = 19) was 83.9 ± 10.3% and 82.2 ± 11.5% in the conventional group (n = 21) (p = 0.630). Minimal stent area was 6.6 ± 1.5 mm2 and 6.2 ± 1.8 mm2, respectively (p = 0.406). No periprocedural, in-hospital and 30-day follow-up major adverse cardiac event (MACE) were reported. The authors concluded that in severely calcified coronary lesions there were no significant difference in stent expansion measured by OCT when comparing IVL, as plaque modification, with conventional and/or specialty angioplasty balloons.

 Section Summary

Coronary intravascular lithotripsy (IVL) is a relatively new technology. The evidence reviewed includes six systematic reviews (SR) and two recent randomized clinical trials. All SRs are based on single armed studies and in mostly male subjects. Most of the evidence of safety and effectiveness of Coronary IVL extends from the four prospective, nonrandomized, single arm, manufacturer sponsored, multisite DISRUPT CAD studies: Disrupt CAD I (NCT02650128); Disrupt CAD II (NCT03328949); Disrupt CAD III; and Disrupt CAD IV (NCT04151628), which predisposes to publication bias. Two randomized trials were recently published including a prospective non-inferiority trial (n = 70) comparing outcomes of IVL or rotational atherectomy (RA) and a prospective study (n = 40) comparing pretreatment with IVL to predilatation with conventional and/or speciality balloon strategy. Both studies suggested IVL is not inferior to the comparator procedures. The RCTs have limitations such as small sample size, mostly male participants, heterogeneity of baseline lumen diameters. Adequately powered randomized controlled trails comparing IVL to currently used procedures are needed to assess the safety and efficacy of IVL.

Objective

The objective of this evidence review is to assess whether the use of  Coronary intravascular lithotripsy improves the net health outcome after treatment of patients with  coronary artery calcification when performed in conjunction with other percutaneous transluminal or transcatheter coronary procedures (angioplasty, atherectomy, stent placement, revascularization of bypass graft or occlusion, or thrombolysis).

Policy Statement

There is not enough research to support the use of coronary intravascular lithotripsy in inviduals with  severely calcified atherosclerotic coronary vascular lesions. No clinical guidelines based on research recommend coronary intravascular lithotripsy. Therefore, coronary intravascular lithotripsy is considered investigational . Notwithstanding, under specific considerations and following clinical  preauthorization, the Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Policy Guidelines

This policy only applies to coronary intravascular lithotripsy. Coronary intravascular lithotripsy is considered investigational for all indications. 

Note, the fact a new service or procedure has been issued a CPT/HCPCS code or is FDA approved for a specific indication does not, in itself, make the procedure medically reasonable and necessary. The FDA determines safety and effectiveness of a device or drug, but does not establish medical necessity. While Medicare may adopt FDA determinations regarding safety and effectiveness, Medicare or Medicare contractors evaluate whether or not the drug or device is reasonable and necessary for the Medicare population under §1862(a)(1)(A).

Benefit Application

BlueCard/National Account Issues

Text

Background

 In 2021, The US Food and Drug administration (FDA) granted Premarket Approval (PMA) for the Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (Product code QMG, PMA number P200039). (1) The Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Rationale

This evidence review was created in April 2024 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through April 17,2024

Population Reference No. 1 Policy Statement

Individuals with  severely calcified atherosclerotic coronary vascular lesions in preparation for stent implantation or other percutaneous coronary interventions

Population Reference No. 2 Policy Statement

Individuals with severely calcified, stenotic de novo coronary arteries prior to stenting.

Suplemental Information

References

1.      FDA (FDA). FDA. Food and Drug Administration; Premarket Approval - Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039). [cited 11/29/2023]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200039S001.

2.      Hennessey B, Pareek N, Macaya F, et al. Contemporary percutaneous management of coronary calcification: current status and future directions. Open Heart. 2023;10(1). PMID: 36796870 2. FDA. Food and Drug Administration; Premarket Approval - Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039). [cited 11/29/2023]. 'Available from:' https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200039S001. SUR233 | 6

3.       FDA. Food and Drug Administration; Summary of Safety and Effectiveness Data - Intravascular Lithotripsy System [cited 11/29/2023]. 'Available from:' https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200039B.pdf.

4.       Caminiti R, Vetta G, Parlavecchio A, et al. A Systematic Review and Meta-Analysis Including 354 Patients from 13 Studies of Intravascular Lithotripsy for the Treatment of Underexpanded Coronary Stents. Am J Cardiol. 2023;205:223-30. PMID: 37611414

5.       Mhanna M, Beran A, Nazir S, et al. Efficacy and Safety of Intravascular Lithotripsy in Calcified Coronary Lesions: A Systematic Review and Meta-Analysis. Cardiovasc Revasc Med. 2022;36:73-82. PMID: 34024748

6.       Sattar Y, Almas T, Arshad J, et al. Clinical and angiographic success and safety comparison of coronary intravascular lithotripsy: An updated meta-analysis. Int J Cardiol Heart Vasc. 2022;39:100975. PMID: 35242998

7.       Kereiakes DJ, Di Mario C, Riley RF, et al. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021;14(12):1337-48. PMID: 33939604

8.       Sattar Y, Ullah W, Virk HUH, et al. Coronary intravascular lithotripsy for coronary artery calcifications- systematic review of cases. J Community Hosp Intern Med Perspect. 2021;11(2):200-05. PMID: 33889320

9.        Sheikh AS, Connolly DL, Abdul F, et al. Intravascular lithotripsy for severe coronary calcification: a systematic review. Minerva Cardiol Angiol. 2023;71(6):643-52. PMID: 34713678

10.     Blachutzik F, Meier S, Weissner M, et al. Coronary intravascular lithotripsy and rotational atherectomy for severely calcified stenosis: Results from the ROTA.shock trial. Catheter Cardiovasc Interv. 2023;102(5):823-33. PMID: 37668088

11.    Blachutzik F, Meier S, Weissner M, et al. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023;197:93-100. PMID: 37012181

12.   Oomens T, Vos NS, van der Schaaf RJ, et al. EXpansion of stents after intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries. Int J Cardiol. 2023;386:24-29. PMID: 37178801

13..Sreenivasan J, Shah A, Riangwiwat T, Jayasree Rajendran R, Vazquez Sosa CE, Gupta R, Frishman WH, Timmermans RJ, Ahmad H, Aronow WS, Ahmad Y.Cardiol Rev. 2024 May-Jun 01;32(3):267-272. doi: 10.1097/CRD.0000000000000502. Epub 2022 Dec 5.PMID: 36541962 Review.

14.Gardiner R, Muradagha H, Kiernan TJ.Expert Rev Cardiovasc Ther. 2022 Apr;20(4):323-338. doi: 10.1080/14779072.2022.2069561. Epub 2022 Apr 25.PMID: 35466834

15. Ali ZA, Kereiakes D, Hill J, Saito S, Di Mario C, Honton B, Gonzalo N, Riley R, Maehara A, Matsumura M, Stone GW, Shlofmitz R.JACC Cardiovasc Interv. 2023 May 8;16(9):1122-1124. doi: 10.1016/j.jcin.2023.02.015. Epub 2023 Apr 5.PMID: 37029020 

16. Regence Medicare Advantage Policy Manual M-SUR233 12/2023

Codes

Policy History